A phase III study comparing Sorafenib with placebo in patients who have had kidney cancer removed (SORCE)
- Conditions
- Renal cancerCancer - Kidney
- Registration Number
- ACTRN12609000048280
- Lead Sponsor
- Medical Research Council
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1711
Histologically proven renal cell carcinoma. No evidence of residual macroscopic disease on post-operative Computerised Tomography (CT) scan after resection of renal cell carcinoma. Patients with clear cell or non-clear cell tumours are eligible. Patients with intermediate or high risk per the Leibovich score 3 to 11. Subjects must be >18 years in age. Women of childbearing age must have a negative pregnancy test and must use adequate contraception during the treatment phase of hte study and for 9 months afterwards. Women who wish to breast feed are not eligible for the study. Adequate bone marrow function (White Blood Cell (WBC) > 3.4 x 109/L, platelets > 99 x 109/L) renal function (creatinine < 2.5 x the Upper Limit of Normal (ULN)) and hepatic function (Liver Function Test (LFT) < 1.5 x ULN) within 14 days prior to randomisation. Patients should have had surgery at least 4 weeks but no more than 3 months (91d) prior to treatment start date. Serum amylase < 1.5 x ULN Prothrombin or International Normalised Ratio (INR) and prothrombin time < 1.5 x ULN World Health Organisation (WHO) performance status 0 or 1. Written informed consent obtained.
Prior anti-cancer treatment for renal cell carcinoma other than nephrectomy Cardiac arrhythmias requiring anti-arrhythmics (beta blockers and digoxin are allowed), symptomatic coronary artery disease or ischaemia, myocardial infarction within the last 6 months, congestive cardiac failure > (New York Heart Association (NYHA) class II. Active clinically serious bacterial or fungal infections. Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C. Pregnant or breast-feeding patients. Prior malignancy (except for cervical carcinoma in situ or adequately treated basal cell carcinoma). Concomitant medications which have adverse interactions with sorafenib: rifampin, grapefruit juice, ritonavir, ketoconazole, itraconazole and St John's Wort. Patients with uncontrolled hypertension.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival, measured by 6-monthly computer tomography (CT) of chest, abomen and pelvis, with 6-monthly chest x-rays in-between.[Baseline, 3 weeks, 6 weeks and 3 months post-randomisation, then 3-monthly until 3 years post-randomisation. 6-monthly chest x-rays only between 3 and 6 years post-randomisation. Yearly chest x-rays only following first 5 years.]
- Secondary Outcome Measures
Name Time Method